CLASS II ONGOING Device recall · Reported 19 Apr 2023 · FDA Enforcement Report
Edward Lifesciences, REF 774F75, Swan-Ganz CCOmbo V recalled
Edwards Lifesciences is recalling Edward Lifesciences, REF 774F75, Swan-Ganz CCOmbo V, distributed in 42 states. The recall was initiated on 14 Feb 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1380-2023
- FDA event ID
- 91868
- Recalling firm
- Edwards Lifesciences, Irvine, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 14 Feb 2023
- FDA classified
- 12 Apr 2023
- Reported
- 19 Apr 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 14 Feb 2023 | Recall initiated by company | |
| 12 Apr 2023 | Classified by FDA | +57 days |
| 19 Apr 2023 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
There is a potential that the distal end of the catheter may be bent beyond its intended curvature and when connected to patient monitoring device, the monitor may display an error message.
Product as listed by the FDA
Edward Lifesciences, REF 774F75, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 7.5F (2.5mm), Usable Length 110 cm, Recommended Guidewire size 0.018 (0.46mm), Minimum Introducer size 8.5F (2.8 mm)
Where it was distributed
US: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA RI SC SD TN TX UT VA WA WI WV WY OUS: None
AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaFloridaGeorgiaIowaIllinoisKansasKentuckyLouisianaMassachusettsMarylandMichiganMinnesotaMissouri
Questions about this recall
Why was it recalled?
There is a potential that the distal end of the catheter may be bent beyond its intended curvature and when connected to patient monitoring device, the monitor may display an error message.
Which lots are affected?
Primary DI Number: 00690103146998/ Lot: 64526520
Where was it sold?
US: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA RI SC SD TN TX UT VA WA WI WV WY OUS: None
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 91868| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Edward Lifesciences, REF 777F8, Swan-Ganz CCOmbo V recalled | Edwards Lifesciences | Other | 42 states |
More recalls from Edwards Lifesciences
All 95| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Edwards Evoque tricuspid delivery system recalled | Edwards Lifesciences | Other | Nationwide |
| Device | CLASS I | Optisite Arterial Cannula recalled by Edwards Lifesciences | Edwards Lifesciences | Device Malfunction | Nationwide |
| Device | CLASS I | Fem-flexii Femoral Arterial Cannula recalled by Edwards Lifesciences | Edwards Lifesciences | Device Malfunction | Nationwide |
| Device | CLASS I | Fem-flex II Femoral Arterial Cannula recalled by Edwards Lifesciences | Edwards Lifesciences | Device Malfunction | Nationwide |
| Device | CLASS I | Fem-flex II Femoral Arterial Cannula recalled by Edwards Lifesciences | Edwards Lifesciences | Device Malfunction | Nationwide |
Other Heart & Vascular Devices recalls
All 6,220| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | TufTex¿ Over-the-Wire Embolectomy Catheter recalled | LeMaitre Vascular | Other | Nationwide |
| Device | CLASS II | Endovascular Pack kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Bard Ep Xt Decapolar Steerable, Diagnostic Ep Catheter, 6f recalled | Stryker Sustainability Solutions | Particulate Matter | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |